CDISC (Clinical Data Interchange Standards Consortium) is a global, non-profit organization that develops standards for the exchange, submission, analysis, and archiving of clinical research data. Its goal is to create a unified framework to improve data quality and interoperability. The most important CDISC standards are SDTM (Study Data Tabulation Model) for submission data and ADaM (Analysis Data Model) for analysis datasets. These standards are mandatory for submissions to regulatory authorities such as the FDA and the Japanese PMDA.
The adoption of CDISC standards enables a seamless and efficient data flow from eCRF to final statistical analysis and submission. For CROs, CDISC expertise is a core competence in data management and biostatistics. It ensures that study data is collected in a standardized manner from the outset, which reduces the time required for data transformation, improves quality, and accelerates the regulatory review process. This is crucial for meeting regulatory requirements and ensuring a smooth approval process.